FDA label 620e053b-22c4-422b-b16a-3093e0601f6e

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
05d5761b-738f-46fa-833c-97901d1164de
SPL ID
620e053b-22c4-422b-b16a-3093e0601f6e
Version
2
Effective date
2014-01-27
Source export date
2026-10-12
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:41:52

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warning: do not use if you are prenant or lactating or have phenylketonuria. Consult your doctor or health care professional before us if you are taking prescription medication for depression such as MAO inhibitors or have asthma, high blood pressure, stomach ulcers, diabetes, or hyperthyroidism. Nicotine or caffeine can increase your heart rate. This product contains nicotine, a chemical known to the state of California to cause birth defects or other reproductive harms. Caution : For any suspected or known illness or dysfunction, always consult your physician or medical adviser first.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.